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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test whether there is a threshold of glucose that will result in improved ease of resistance to problem foods (tested by comparing three different levels of glucose).
Ingestion of 100 calories of glucose during individually pre-determined times of waning dietary self-control will result in improved ease of resistance to problem foods when compared to ingestion of lower calories of glucose or placebo (0 calorie beverage)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (D-B-A-C) | Active Comparator | 100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4. |
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| Sequence 2 (A-D-C-B) | Active Comparator | Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4. |
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| Sequence 3 (C-A-B-D) | Active Comparator | 50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4. |
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| Sequence 4 (B-C-D-A) | Active Comparator | 10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequence 1 | Dietary Supplement | 100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responses to the Control of Eating Questionnaire | Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked "what one food makes it most difficult for you to control eating?" and question #10 asked " What time are you particularly vulnerable to this one food." Higher ratings are consistent with a more significant or more frequent outcome. Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control. | Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James O Hill, PhD | Anschutz Health and Wellness Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anschutz Health and Wellness Center | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24261006 | Background | Hand GA, Shook RP, Paluch AE, Baruth M, Crowley EP, Jaggers JR, Prasad VK, Hurley TG, Hebert JR, O'Connor DP, Archer E, Burgess S, Blair SN. The energy balance study: the design and baseline results for a longitudinal study of energy balance. Res Q Exerc Sport. 2013 Sep;84(3):275-86. doi: 10.1080/02701367.2013.816224. | |
| 23823705 |
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Note, that each subject participated in the study for four weeks, consuming a different study beverage daily for one week, being crossed-over to another beverage the following week. Thus a total of 33 subjects completed all four weeks of the cross-over study.
Subjects were recruited using study flyers and the study was posted on the Center website.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 (D-B-A-C) | Subjects assigned to sequence 1 received 100 calorie beverage in week 1, 10 calorie beverage in week 2, 0 calorie control beverage in week 3, and 50 calorie beverage in week 4. |
| FG001 | Sequence 2 (A-D-C-B) | Subjects in sequence 2 received 0 calorie control beverage in week 1, 100 calorie beverage in week 2, 50 calorie beverage in week 3, and 10 calorie beverage in week 4. |
| FG002 | Sequence 3 (C-A-B-D) | Subjects in sequence 3 received 50 calorie beverage in week 1, 0 calorie control beverage in week 2, 20 calorie beverage in week 3, and 100 calorie beverage in week 4. |
| FG003 | Sequence 4 (B-C-D-A) | Subjects in sequence 4 received 10 calorie beverage in week 1, 50 calorie beverage in week 2, 100 calorie beverage in week 3, and 0 calorie control beverage in week 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Week) |
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| Second Intervention (1 Week) |
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| Third Intervention (1 Week) |
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| Fourth Intervention (1 Week) |
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37 subjects were screened and enrolled into the study. Each subject was randomized to a different sequence of consumption of the weekly study beverage. 33 subjects completed the 4 week study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Subjects | Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. Glucose: This is a randomized, double-blind cross-over pilot study involving 40 study subjects. We will compare the efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. After baseline data collection, eligible participants will be randomized into one of the four sequence group and receive a different beverage each week. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Responses to the Control of Eating Questionnaire | Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked "what one food makes it most difficult for you to control eating?" and question #10 asked " What time are you particularly vulnerable to this one food." Higher ratings are consistent with a more significant or more frequent outcome. Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order). | 33 participants completed the 4 week study and were randomized to one of four treatment sequences. Thus, each subject received each treatment for one week. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
Adverse event data were collected during the four-week study for each study participant.
Adverse events were collected without regard for the intervention that was being administered.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Subjects | Subjects were randomized into four possible sequences: subjects assigned to sequence 1 received the control beverage first during week 1, then the 10 calorie beverage during week 2, then the 50 calorie beverage during week 3, and then the 100 calorie beverage during week 4. Subjects assigned to sequence 2 received received the 50 calorie beverage during week 1, then the 100 calorie beverage during week 2, then the control beverage during week 3, and then the 50 calorie beverage during week 4. Subejcts assigned to sequence 3 received the 50 calorie beverage during week 1, then the control beverage during week 2, then the 100 calorie beverage during week 3, and then the 10 calorie beverage during week 4. Subjects assigned to sequence 4 received the 100 calorie beverage during week 1, then the 50 calorie beverage during week 2, then the 10 calorie beverage during week 3, and then the control beverage during week 4. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders |
The study questionnaire involved limitations as questions were subjective in terms of how subjects defined cravings and snacking behavior. Also, food diaries may not be fully accurate accounts of subjects' actual caloric intake and food consumption.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Hill | University of Colorado, Anschutz Health and Wellness Center | 303-724-9974 | james.hill@ucdenver.edu |
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| ID | Term |
|---|---|
| D000068356 | Self-Control |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| Sequence 2 | Dietary Supplement | Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4. |
|
| Sequence 3 | Dietary Supplement | 50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4. |
|
| Sequence 4 | Dietary Supplement | 10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4. |
|
| 4 weeks |
| Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week. | Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose. | 4 weeks |
| Chang SH, Pollack LM, Colditz GA. Life Years Lost Associated with Obesity-Related Diseases for U.S. Non-Smoking Adults. PLoS One. 2013 Jun 18;8(6):e66550. doi: 10.1371/journal.pone.0066550. Print 2013. |
| 23147189 | Background | Dulloo AG. Explaining the failures of obesity therapy: willpower attenuation, target miscalculation or metabolic compensation? Int J Obes (Lond). 2012 Nov;36(11):1418-20. doi: 10.1038/ijo.2012.114. No abstract available. |
| 18315798 | Background | Masicampo EJ, Baumeister RF. Toward a physiology of dual-process reasoning and judgment: lemonade, willpower, and expensive rule-based analysis. Psychol Sci. 2008 Mar;19(3):255-60. doi: 10.1111/j.1467-9280.2008.02077.x. |
| Background | Littell, Ramon C., George A. Milliken, Walter W. Stroup, Russell D. Wolfinger, and O Schabenberger. 2006. SAS@ for Mixed Models, Second Edition. Cary, NC: SAS Institute. |
| 18453466 | Result | Gailliot MT, Baumeister RF. The physiology of willpower: linking blood glucose to self-control. Pers Soc Psychol Rev. 2007 Nov;11(4):303-27. doi: 10.1177/1088868307303030. |
| 23751109 | Result | Hofmann W, Adriaanse M, Vohs KD, Baumeister RF. Dieting and the self-control of eating in everyday environments: an experience sampling study. Br J Health Psychol. 2014 Sep;19(3):523-39. doi: 10.1111/bjhp.12053. Epub 2013 Jun 10. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG000 |
| Control |
Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week. |
| OG001 | 100 Calorie Glucose Beverage | Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week. |
| OG002 | 50 Calorie Beverage | Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week. |
| OG003 | 10 Calorie | Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week. |
|
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| Secondary | Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control. | Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose. | 33 subjects completed the 4 week study. | Posted | Mean | Standard Deviation | percentage of days in a week | 4 weeks |
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| Secondary | Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week. | Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose. | 33 subjects completed the 4 week study. | Posted | Mean | Standard Deviation | percentage of days in a week | 4 weeks |
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| 0 |
| 37 |
| 9 |
| 37 |
| fever | General disorders |
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| migraine | General disorders |
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| stomach ache | Gastrointestinal disorders |
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| jitteriness | General disorders |
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| Flu | General disorders |
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| bursitis | Musculoskeletal and connective tissue disorders |
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| dry mouth | General disorders |
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| upset stomach | Gastrointestinal disorders |
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| diarrhea | Gastrointestinal disorders |
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| nausea | Gastrointestinal disorders |
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| bloating | Gastrointestinal disorders |
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